Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07336797

Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy

Led by Abdelrahman Mahmoud · Updated on 2026-01-13

66

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

We investigate the role of empagliflozin in the treatment of obesity in PLWH.

CONDITIONS

Official Title

Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years and up to 65 years old
  • Body Mass Index (BMI) greater than 30 kg/m²
  • Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen with dolutegravir
  • Sustained virologic suppression with HIV-1 RNA less than 200 copies/mL for at least 6 months
  • Current CD4 count greater than 250 cells/mL
  • Ability and willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of Diabetes Mellitus with fasting blood glucose greater than 126 mg/dL or HbA1c greater than 6.5%
  • Renal impairment with eGFR less than 60 ml/min/1.73m²
  • Active viral hepatitis B or C infection
  • Hypersensitivity to empagliflozin or its components
  • Pregnancy or breastfeeding
  • Current use of other SGLT-2 inhibitors
  • Use of drugs that interact with empagliflozin or dolutegravir (e.g., rifampin, phenytoin, antacids, carbamazepine)
  • Current or recent use of medications known to cause significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers)
  • Known thyroid disease with TSH greater than 6.0 mIU/L or less than 0.35 mIU/L

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo

Cairo, Egypt, 11562

Actively Recruiting

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Research Team

A

Abdelrahman Dosoky, Bachelor's degree

CONTACT

A

Ahmed Kamel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy | DecenTrialz